Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K242323

Maestro System (REF100)

510(k) number
K242323
Device name
Maestro System (REF100)
Applicant
Moon Surgical FR
Product code
QZB — Software Controlled Endoscope And Instrument Holder
Decision date
2025-03-14
Date received
2024-08-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K242323.pdf

Official FDA record: K242323
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.